MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P FULL DOSE 1 PACK; BONE CEMENT

Catalog Number 6191-1-001

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Information (3190); Insufficient Information (4580)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported, "she had a total shoulder where the doctor used expired bone cement (simplex p6191), and required revision.She inquired where she could find the instructions for use, particularly any sections pertaining to the use of expired cement.".

Manufacturer Narrative

Reported event: an event regarding expired - off label and loosening involving a simplex cement mix was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  complaint history review: there have been no other similar events for the reported lot.  conclusions: review of the device history records for the reported device, simplex p full dose 1 pack, catalog: 6191-1-001, lot: rku173, indicate 235 ten-packs were manufactured and accepted into final stock on 12 nov, 2013, with the expiration date of aug, 2016.Based on the dhr information the device was not expired at the time of surgery.The exact cause of the event could not be determined because insufficient information was provided.Further information such as post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.

Event Description

It was reported, "she had a total shoulder where the doctor used expired bone cement (simplex p6191), and required revision.She inquired where she could find the instructions for use, particularly any sections pertaining to the use of expired cement.".

• Brand Name: SIMPLEX P FULL DOSE 1 PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10753620
• MDR Text Key: 213641844
• Report Number: 0002249697-2020-02270
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RKU173
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR